Medicina
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Randomized Controlled Trial Multicenter Study
A Randomized, Multicenter, Double-Blind, Parallel, Non-Inferiority Clinical Study to Compare the Efficacy and Safety of Unicenta and Melsmon for Menopausal Symptom Improvement.
This study was conducted to evaluate the efficacy and safety of Unicenta in female subjects with menopausal symptoms by analyzing the changes in the Kupperman index (primary endpoint) and hormonal changes (secondary endpoint). It was a randomized, multi-center, double-blind, parallel, non-inferiority clinical study conducted at two different tertiary medical centers. A Unicenta injection was shown to be non-inferior to Melsmon based on the Kupperman index in both the intent-to-treat and per-protocol populations (p = 0.789 and p = 0.826, respectively). ⋯ There was no statistically significant difference in the incidence rate of adverse events between the two groups (p = 0.505). The study demonstrated that Unicenta is not inferior to Melsmon in terms of the change in the Kupperman index after 12 days of injection. The efficacy and safety of Unicenta were shown, resulting in the improvement of menopausal symptoms.
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Randomized Controlled Trial
Evaluation and Performance of a Positive Airway Pressure Device (CPAP-AirFlife™): A Randomized Crossover Non-Inferiority Clinical Study in Normal Subjects.
Background and Objectives: During the COVID-19, the demand for non-invasive ventilatory support equipment significantly increased. In response, a novel non-invasive ventilatory support model called CPAP-AirFlife™ was developed utilizing existing technologies. This model offers technological advantages, including an aerosol-controlled helmet suitable for high-risk environments such as ambulances. ⋯ Its technological advantages, including the aerosol-controlled helmet, make it suitable for high-risk environments. The device's accessibility and affordability make it a promising solution for implementation in low-level hospitals, particularly in rural areas. This study supports using CPAP-AirFlife™ as a practical option for non-invasive ventilatory support, providing a valuable contribution to respiratory care during the COVID-19 pandemic and beyond.
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Randomized Controlled Trial
The Effects of Cardiac Rehabilitation including Nordic Walking in Patients with Chronic Coronary Syndromes after Percutaneous Coronary Interventions in Elective Mode.
Background: Percutaneous coronary intervention (PCI) in patients with chronic coronary syndrome (CCS) is a worldwide method of coronary revascularisation. The aim of this study was to assess the immediate and long-term effects of Nordic Walking (NW) training added to a standard cardiac rehabilitation programme on physical activity (PA) and capacity and life quality, as well as selected proatherogenic risk factors. Methods: The studied group comprised 50 patients (considering exclusion criteria, 40 patients), aged 56-70, with CCS after elective PCI qualified them for a 6-weeks-long cardiac rehabilitation. ⋯ Both at the I follow-up and II follow-up time points, a significant increase in the walking distance was noted in the control and experimental groups compared to baseline, and the difference between both groups was significant at the end of follow-up (378.57 ± 71.35 vs. 469.29 ± 58.07, p = 0.003). Moreover, NW had a positive effect on the modulation within selected biochemical risk factors of atherosclerosis, as well as subjective quality of life and well-being. Conclusions: Introducing NW training into the cardiac rehabilitation process proved to be a more effective form of therapy in patients with CCS treated via PCI, as compared to the standard cardiac rehabilitation programme alone.
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Randomized Controlled Trial
Efficacy of Aceclofenac and Ilaprazole Combination Therapy versus Celecoxib Monotherapy for Treating NSAID-Induced Dyspepsia in Lumbar Spinal Stenosis Patients.
Background and Objectives: Dyspepsia is a common adverse event associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with lumbar spinal stenosis. Although proton pump and cyclooxygenase-2 inhibitors are potential treatment options, the optimal strategy remains unclear. This study aimed to compare the efficacy and safety of combination therapy with aceclofenac and ilaprazole versus celecoxib monotherapy for the treatment of dyspepsia caused by NSAID use in patients with lumbar spinal stenosis. ⋯ SF-12 scores did not differ significantly between the two groups. Adverse events were reported in both groups, but there was no significant difference in incidence. Conclusions: Combination therapy with aceclofenac and ilaprazole can be a treatment option for NSAID-induced dyspepsia in some situations.
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Randomized Controlled Trial
A Comparative Analysis of Pain Control Methods after Ankle Fracture Surgery with a Peripheral Nerve Block: A Single-Center Randomized Controlled Prospective Study.
Background and Objectives: Patients experience severe pain after surgical correction of ankle fractures. Although their exact mechanism is unknown, dexamethasone and epinephrine increase the analgesic effect of anesthetics in peripheral nerve blocks. This study aimed to compare the postoperative pain control efficacy of peripheral nerve blocks with ropivacaine combined with dexamethasone/epinephrine and peripheral nerve blocks with only ropivacaine and added patient-controlled analgesia in patients with ankle fractures. ⋯ Satisfaction scores were significantly higher in group B (p = 0.003). There were no anesthesia-related complications in either group. Conclusions: Dexamethasone and epinephrine as adjuvant anesthetic solutions can effectively control pain when performing surgery using peripheral nerve blocks for patients with ankle fractures.